Overview
Research & Development
We work closely with our clients from the earliest stage of a product’s life cycle: research and development. Our firm’s work representing academic medical centers, research institutes and universities, in addition to global life sciences companies, provides a unique perspective when counseling clients on pre-clinical and clinical research and development activities. We regularly counsel FDA-regulated companies on product development and clinical research, FDA Investigational New Drug (IND) and Investigational Device Exemption (IDE) requirements, human subjects protections, compliance with Good Clinical Practice (GCP) standards, clinical trial registration and results reporting, and adverse event reporting. We help clinical sites and research sponsors develop and implement research policies, procedures and templates to ensure compliance with legal requirements, protect business interests, and facilitate research activities.
Regulatory Strategy & Product Approvals
Obtaining FDA approval or clearance to market drugs, biologics, medical devices, and food additives – especially those that have encountered difficulties in the approval process – requires experienced counsel. Our team has that experience and regularly advises clients to help them leverage development and approval incentives, select optimal regulatory pathways, prepare for advisory committee meetings, manage inspection readiness, respond to complex inquiries from the FDA, and appeal adverse regulatory decisions.
Life Cycle Management
Strategic, knowledgeable legal advice is essential to understanding and applying statutory provisions that confer exclusive marketing rights on FDA-regulated products. These laws, including the Hatch-Waxman Act; the Orphan Drug Act; the pediatric exclusivity provisions of the Federal Food, Drug, and Cosmetic Act;and the Biologics Price Competition and Innovation Act; are highly complex and subject to misinterpretation. Our decades of experience providing advice in this area and our in-depth understanding of the relationship between patent and nonpatent exclusivity rights enable us to help our clients receive maximum exclusivity rights permitted by law.
